NRx Pharmaceuticals Reveals Final Trial Results: NRX-101 Safer, Equally Effective as Lurasidone in Suicidal Bipolar Depression

Recent findings indicate that NRX-101, developed by NRx Pharmaceuticals, offers a significant safety advantage over the current standard of care for treating suicidal bipolar depression. A recent clinical trial showed that NRX-101 led to a mean 76% reduction in symptoms of akathisia compared to lurasidone, with the effect being sustained over 42 days. Akathisia, a serious side effect linked to antidepressants and associated with increased suicide risk, was observed in only 2% of participants treated with NRX-101, compared to 11% in those treated with lurasidone.

The clinical trial enrolled 91 participants who had not been pre-treated with ketamine, demonstrating comparable antidepressant effects between NRX-101 and lurasidone. Although a 33% decrease in suicidality was noted in the NRX-101 group, it was not statistically significant. Nonetheless, the reduced incidence of akathisia alone provides a basis for seeking accelerated FDA approval.

This finding aligns with previous results from the Company's STABIL-B trial and is supported by the FDA Special Protocol Agreement. NRx Pharmaceuticals plans to present the full clinical trial results at the upcoming American Society of Clinical Psychopharmacology meeting in Miami, scheduled for May 28-31, 2024. The company will also host a broadcast presentation on akathisia and antidepressant safety, followed by an investor Q&A session.

Based on these promising results, NRx Pharmaceuticals intends to seek accelerated approval of NRX-101 for treating bipolar depression in patients at risk of akathisia. The company also aims to expand the drug's indications to cover all patients with bipolar depression and potentially those with schizophrenia. If further large-scale trials confirm these findings, NRX-101 could become a preferred treatment option due to its reduced risk of akathisia.

The company draws parallels with the recent approval of LYBALVI, a combination of olanzapine and samidorphan, which was approved based on comparable efficacy with fewer side effects related to weight gain. NRx Pharmaceuticals argues that similar considerations should apply to NRX-101, particularly given the high stakes associated with treating bipolar depression, a condition affecting over 7 million Americans with a significant risk of suicide.

Professor Daniel Javitt, a co-founder of NRx Pharmaceuticals, emphasized the groundbreaking nature of these findings. He noted that prior rodent model studies had shown that NRX-101's active ingredient, D-cycloserine, could reverse akathisia-like behaviors induced by lurasidone. The recent clinical trial results corroborate these earlier findings and pave the way for potentially life-saving treatments for patients with suicidal depression.

NRx Pharmaceuticals' portfolio focuses on developing NMDA-based therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD. The company is also exploring the use of NRX-101 as a non-opioid treatment for chronic pain and a therapy for complicated urinary tract infections (UTIs). Partnered with Alvogen and Lotus, NRx Pharmaceuticals is advancing the development and marketing of NRX-101.

In addition to NRX-101, the company plans to submit a New Drug Application for HTX-100, an intravenous form of ketamine, through its subsidiary HOPE Therapeutics. This submission follows promising results from clinical trials conducted under the US National Institutes of Health and new data from French health authorities. HTX-100 has been awarded Fast Track Designation by the FDA for treating acute suicidality.

The findings related to NRX-101 offer hope for a new, safer treatment option for millions of patients struggling with suicidal bipolar depression, marking a significant step forward in the field of psychopharmacology.